Counterfeit pharmaceuticals

Malaria Centre member Harparkash Kaur invited to author chapter for UK Government Office for Science report on Forensic Science

The United Nations Office on Drugs and Crime has identified pharmaceutical counterfeiting as a global threat that can kill patients, contribute to the rise of drug resistance, and increase the citizens’ mistrust of health systems. Although health professionals assume that they are prescribing good-quality medications, and patients assume that these medications will cure them, counterfeit drugs are often revealed only after a patient fails to recover.

Antimalarial drugs are a vulnerable target and most of the work on determining the quality of formulations has focused on them. Considerable technical, financial and human resources are required to inspect, analyse and police the drug supply, all of which are lacking in most malaria-endemic countries. A systematic review of the literature reveals that few surveys of antimalarial medicines have used robust methodology, and that the majority do not differentiate between substandard and falsified medicines. Whilst there are no universally accepted definitions of poor quality drug categories; falsified formulations are the ones without the stated active pharmaceutical ingredient (SAPI) and may carry false representation of their source of identity. Substandard drugs are produced with inadequate attention to good manufacturing practices and may have contents or dissolution times that are outside accepted limits, due to poor quality control. Degraded formulations may result from exposure of good-quality medicines to light, heat, and humidity. It can be difficult to distinguish degraded medicines from those that left the factory as substandard, but the distinction is important because the causes and remedies will be different. Drug surveys requires epidemiological expertise, and an adequate sample size from as wide a range of outlets as possible, to provide a reliable estimate of the frequency of poor quality drugs. Reliable methods that conform to internationally accepted standards are essential to justify and promote the political action that would create the mechanisms needed to assure drug quality.

To monitor drug quality pharmaceutical companies, governments and health programs must invest in the regulations, technologies, and infrastructure needed; including anti-counterfeiting measures, specialised analytical facilities run by experienced staff, and portable technologies for screening medicines in the field. This chapter by Dr Harparkash Kaur discusses techniques that can be used to determine the quality of drugs and highlights the need for more research funding to uncover the extent of the counterfeiting problem; to evaluate appropriate methods for drug-quality assessment; and to estimate the impact of poor-quality drugs used to treat various diseases. As more people travel around the world, there is an urgent need to ensure that medicines available globally are of good quality.